FDAClass IIFebruary 19, 2020

Medicrea TLIF-B Holder recall

Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

Why was Medicrea TLIF-B Holder recalled?

Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers l9B0570; 19B0572

Product
Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Recalling firm
Medicrea International
Quantity
14 units
Distribution
OH, VA
Recall date
February 19, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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